EP0728488A1 - Sack mit Pumpeinheit, insbesondere für Herzunterstützungsvorrichtungen - Google Patents

Sack mit Pumpeinheit, insbesondere für Herzunterstützungsvorrichtungen Download PDF

Info

Publication number
EP0728488A1
EP0728488A1 EP96102509A EP96102509A EP0728488A1 EP 0728488 A1 EP0728488 A1 EP 0728488A1 EP 96102509 A EP96102509 A EP 96102509A EP 96102509 A EP96102509 A EP 96102509A EP 0728488 A1 EP0728488 A1 EP 0728488A1
Authority
EP
European Patent Office
Prior art keywords
bag
thrust element
motor
drive unit
abutment surface
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP96102509A
Other languages
English (en)
French (fr)
Other versions
EP0728488B1 (de
Inventor
Maurizio Zagara
Maurizio Arabia
Bruno Mambrito
Enrico Ferri
Silvia Chieco
Marco Giannitrapani
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ministero dell Universita e della Ricerca Scientifica e Tecnologica (MURST)
Original Assignee
Ministero dell Universita e della Ricerca Scientifica e Tecnologica (MURST)
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ministero dell Universita e della Ricerca Scientifica e Tecnologica (MURST) filed Critical Ministero dell Universita e della Ricerca Scientifica e Tecnologica (MURST)
Publication of EP0728488A1 publication Critical patent/EP0728488A1/de
Application granted granted Critical
Publication of EP0728488B1 publication Critical patent/EP0728488B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/424—Details relating to driving for positive displacement blood pumps
    • A61M60/438—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical
    • A61M60/441—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical generated by an electromotor
    • A61M60/443—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical generated by an electromotor with means converting the rotation into a translational movement of the displacement member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/196—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body replacing the entire heart, e.g. total artificial hearts [TAH]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/835—Constructional details other than related to driving of positive displacement blood pumps
    • A61M60/837—Aspects of flexible displacement members, e.g. shapes or materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857—Implantable blood tubes
    • A61M60/859—Connections therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices

Definitions

  • the present invention relates to bags and to pumping units for pumps.
  • the invention has been developed with particular attention to its possible use in the production of pumps for cardiac assistance devices (artificial ventricles, artificial hearts, etc.).
  • the scope of the invention is not intended to be limited to this specific field of application, however, but extends to the pumping of fluids in general, principally with regard to the pumping of fluids in the biomedical field.
  • pumps each comprising a compressible pumping element in the form of a bag and a thrust element (a plate) which acts on the bag in order to compress it cyclically, the bag being housed in a respective shell.
  • a pump of this type may be operated by a rotary motor with an associated screw which converts the movement of the rotor of the motor into the translational movement of the plate.
  • the bag-like element can be used with great efficiency and hence with the ability to change from a fully-extended volume to a fully-compressed volume which is virtually zero, without the formation of areas in which the pumped fluid (for example, blood) is stagnant and/or spaces which are not used for the purposes of the pumping action. This is also desirable on account of the fact that any stagnant areas of the blood inside the bag may give rise to thromboses.
  • the pumped fluid for example, blood
  • the object of the present invention is to provide a bag and, in a further aspect, a pumping unit, for pumps which can satisfy the requirements expressed above in an excellent manner, overcoming the intrinsic problems of the solutions of the prior art.
  • this object is achieved by virtue of a bag and of a drive unit for pumps having the specific characteristics recited in the following claims.
  • a cardiac assistance device constituted specifically by a so-called artificial ventricle is generally indicated 10.
  • the device 10 is housed in a casing or shell 12 of material compatible with the requirements for implantation in the body (for example, titanium).
  • a pumping section or unit 14 a pumping section or unit 14 and an actuating section 16 comprising an electromechanical actuator which drives the pumping unit 14.
  • the latter is constituted essentially by a cup-shaped portion 12a of the shell 12 having connectors 18 (only one of which is visible in Figures 1 and 2, which correspond, as stated, to a diametral section of the casing of the device 10 which is approximately cylindrical in shape) for connection to the blood suction and delivery lines.
  • the shell portion 12a houses a flexible bag 20 which is intended in use to be connected sealingly to the blood lines connected to the device 10, usually with the interposition of valves (not shown) which regulate the blood flow through the blood lines and the device 10 so as to achieve a pulsed one-way flow.
  • the bag 20 is usually made of a flexible material such as, for example, polyurethane, having biocompatibility (haemocompatibility) characteristics.
  • the pumping action takes place as a result of the cyclic compression of the bag 20 brought about by means of a thrust member such as a plate 22 movable to and fro along a respective central axis X22.
  • a thrust member such as a plate 22 movable to and fro along a respective central axis X22.
  • the bag 20 is interposed between the base of the cup-shaped portion 12a of the shell 12 and the plate 22.
  • the reciprocating movement of the plate 22 along the axis X22 (which usually corresponds to the central axis of the cup-shaped portion 12a) takes place under the action of a motor, typically constituted by an electric motor 24.
  • a motor typically constituted by an electric motor 24.
  • This is usually a brushless motor having an approximately disc-like shape and composed of an annular outer stator 26 which is fitted in the mouth portion of the portion 12b of the shell 12 which encloses the actuating section 16, and of a central rotor 28.
  • a motor such as the motor 24 is available commercially and produced by Inland Motors, a division of the Kollmorgen Corporation (Illinois, United States).
  • the rotor 28 incorporates in a central position, that is, in alignment with the axis X22, (or is itself configured in the form of) a lead screw 30 with which a screw 32 is engaged.
  • a lead screw 30 with which a screw 32 is engaged.
  • This is preferably a ball-bearing screw 32 of which the end facing and projecting towards the pumping section 14 is fixed to the plate 22.
  • the screw 32 is a screw with a telescopic structure comprising:
  • the plate 22 is restrained against rotation which may be induced by the motor 24 by the presence of a pin 118 which extends from the shell portion 12b towards the interior of the shell 12 in alignment with the axis X22, the pin 118 having a prismatic cross-section complementary with the cross-section of an axial hole in the inner element 112 of the screw 32.
  • the cyclic pumping of the blood by the device 10 takes place by means of a reciprocating translational movement of the plate 22 along the axis X22.
  • This movement is brought about by the rotation of the motor 24 alternately in the two senses.
  • the rotary movement of the motor 24 and the resulting translational movement of the plate 22 are also associated with a cyclic contraction and extension of the screw 32, owing to its telescopic structure.
  • the most retracted position of the plate 22 in which it is close to the motor 24 corresponds to the arrangement of the screw 106 in the most axially contracted condition shown in Figure 2; in this situation, the inner element 112 is completely, or almost completely, housed in the sleeve 110 which in turn is almost completely housed in the lead screw 108, the axial dimensions of which are determined so as to correspond essentially to the axial thickness of the motor 24.
  • the motor 24 has a stator 26 with generally smaller radial dimensions than the shell 12 and, more specifically, than the plate 22.
  • a rotor element 100 to be keyed to the rotor 28 of the motor 24, the rotor element 100 having a skirt portion 102 with locally differentiated surface characteristics, for example, owing to the presence of notches, which extends around the periphery of the stator 26 forming an annular space in which electro-optical sensors (detector unit) 104 are located.
  • This is in order to form (according to a known solution) a so-called optical encoder the function of which is to detect the rotation parameters of the motor 24 (particularly the position reached by the motor 24 during rotation) so as to be able to obtain an incremental position reference during the detection of the movement of the plate 22.
  • the location of the element 100 in a position at least partially surrounding the stator 26 of the motor 24 and the selection of radial dimensions smaller than those of the plate 22 which has a generally cup-shaped configuration with its cavity facing towards the motor 24, means that, in the most retracted position of Figure 2, the plate 22 can be retracted until its base surface is practically in contact with the corresponding surface of the element 100. This enables optimal use to be made of the relative movement space, consequently minimizing the axial dimensions of the device 10 as a whole.
  • the bag 20 is constructed (with the use of widely known materials and techniques which do not need to be described in detail herein) in the form of an element with a main disc-shaped body (an internal pumping volume) comprising, in the extended condition (Figure 2), two opposed faces 202, 204 preferably with circular profiles, connected by an edge portion 206.
  • the edge 206 has a substantially circular profile, that is, a profile in which two symmetrical, complementary portions can be distinguished, each corresponding approximately to a quarter of a circle.
  • a circular profile for the peripheral edge of the bag is to be considered preferable for the purposes of structural simplicity and efficiency of operation, the same general principle may also be used in bags of different shapes, for example, bags in which the profile of the peripheral edge (observed in a diametral plane relative to the bag) has, for example, a parabolic, elliptical, or mixtilinear shape, provided that the portion of the bag 20 which is exposed to the action of the plate 22 has a shape such that it can be "turned inside out to a complementary position" that is, this portion can be brought to lie, with form coupling, inside the other portion of the bag which is in contact with the cup-shaped portion 12a of the shell 12.
  • both the plate 22 and the cup-shaped portion 12a of the shell 12 and principally the base portion of the cup-shaped portion
  • both the plate 22 and the cup-shaped portion 12a of the shell 12 have exactly complementary cup shapes (for example, in the embodiment shown, with a flat circular base surrounded by an edge with a quarter-circular profile) so as to define the shape to which the portion of the bag which is subjected to the action of the plate 22 is turned inside out to a complementary position inside the remaining portion of the bag.
  • the result just described could also be achieved if the portion of the bag 20 which is intended to be brought into contact with the shell 12 (the portion including the base wall 202) were made of a more or less rigid material, or in any case a more rigid material than the rest of the bag 20 which has to be turned inside out in order to change from the extended position to the compressed position under the action of the plate 22.
  • this rigid portion of the bag could even be wholly or partly replaced by, and thus merged with, the base of the cup-shaped portion 12a of the shell 12, possibly including the connectors 18 connected thereto.
  • the generally disc-like configuration imparted to the bag 20 enables the base of the cup-shaped portion 12a to be made substantially level with the connectors 18 which, in contrast with what usually occurs in solutions according to the prior art, do not project at all, even locally, from the imaginary plane in which the wall or base is situated.
  • This crushing is brought about according to a principle of the maintenance of a constant cross-sectional area: if the net desired cross-sectional area of the extensions 208 is defined at their distal, outer ends relative to the bag 20, the heights of the extensions, measured in the direction in which the portions 202, 204 face one another and hence in the direction of movement of the plate 22 are gradually reduced, the lines simultaneously being widened in a circumferential direction relative to the body of the bag 20; this takes place whilst a constant net value of the cross-sectional areas of the lines 208 is maintained.
  • the heights of the extensions 208 measured in the direction in which the bag is crushed and their widths measured circumferentially relative to the body of the bag 20 thus increase and decrease, respectively, in a complementary manner, in the direction away from the body of the bag 20.
  • Each insert 210 comprises a base portion 212 which is intended to extend inside the cup-shaped portion 12a so as to ensure that the continuity of its peripheral wall is substantially maintained, as well as a projecting portion 214 which can be defined as approximately "fin-shaped" and which is intended to extend into the respective connector 18 so as to form a partial obstruction of its opening, the extent of the obstruction decreasing gradually towards the distal end of the connector 18. This achieves, in a complementary manner, the necessary gradual increase in height and gradual reduction in width of the extension 208 which is intended to extend inside the respective connector 18.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Prostheses (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP96102509A 1995-02-23 1996-02-20 Sack mit Pumpeneinheit, insbesondere für Herzunterstützungsvorrichtungen Expired - Lifetime EP0728488B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITTO950133 1995-02-23
IT95TO000133A IT1278956B1 (it) 1995-02-23 1995-02-23 Sacca per elementi pompanti quali, ad esempio, elementi pompanti di dispositivi per assistenza cardiaca, e relativo gruppo di pompaggio.

Publications (2)

Publication Number Publication Date
EP0728488A1 true EP0728488A1 (de) 1996-08-28
EP0728488B1 EP0728488B1 (de) 2002-10-23

Family

ID=11413256

Family Applications (1)

Application Number Title Priority Date Filing Date
EP96102509A Expired - Lifetime EP0728488B1 (de) 1995-02-23 1996-02-20 Sack mit Pumpeneinheit, insbesondere für Herzunterstützungsvorrichtungen

Country Status (4)

Country Link
EP (1) EP0728488B1 (de)
AT (1) ATE226455T1 (de)
DE (1) DE69624391T2 (de)
IT (1) IT1278956B1 (de)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1066840A1 (de) 2000-04-28 2001-01-10 Ministero Dell' Universita' E Della Ricerca Scientifica E Tecnologica Vorrichtung zur Unterstützung der Funktion einer Herzkammer
EP1466635A1 (de) 2003-04-08 2004-10-13 Ministero dell'Istruzione, dell'Universita e della Ricerca Ventrikelunterstützungsvorrichtung sowie Zubehör dafür

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4222127A (en) * 1978-06-02 1980-09-16 Donachy And Pierce Blood pump and method of pumping blood
EP0478499A1 (de) * 1990-09-26 1992-04-01 GebràœDer Sulzer Aktiengesellschaft Intermittierend fördernde Pumpe

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4222127A (en) * 1978-06-02 1980-09-16 Donachy And Pierce Blood pump and method of pumping blood
EP0478499A1 (de) * 1990-09-26 1992-04-01 GebràœDer Sulzer Aktiengesellschaft Intermittierend fördernde Pumpe

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1066840A1 (de) 2000-04-28 2001-01-10 Ministero Dell' Universita' E Della Ricerca Scientifica E Tecnologica Vorrichtung zur Unterstützung der Funktion einer Herzkammer
US6569079B2 (en) 2000-04-28 2003-05-27 Ministero Dell'universita E Della Ricerca Scientifica E Tecnologica Ventricular assist device, accessory therefore and method of use
EP1466635A1 (de) 2003-04-08 2004-10-13 Ministero dell'Istruzione, dell'Universita e della Ricerca Ventrikelunterstützungsvorrichtung sowie Zubehör dafür

Also Published As

Publication number Publication date
ATE226455T1 (de) 2002-11-15
DE69624391T2 (de) 2003-07-17
IT1278956B1 (it) 1997-12-02
ITTO950133A1 (it) 1996-08-23
EP0728488B1 (de) 2002-10-23
ITTO950133A0 (it) 1995-02-23
DE69624391D1 (de) 2002-11-28

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